The latest data dabigatran real-world analysis and publication of specific reversal agent idarucizumab

Recently, one from the more than 44,000 patients on dabigatran (Thai complete full ®) analysis of the real world and the two most recent data on specific reversal agents idarucizumab dabigatran in the 2015 American Heart Association (AHA) Scientific Sessions on the announcement.
The former is aimed to assess dabigatran compared with warfarin, a new interim analysis for safety and efficacy of long-term studies of routine clinical practice results. The meta-analysis of data from two large US commercial health insurance company database, compared with warfarin therapy in patients with atrial fibrillation, receiving dabigatran treatment of patients with non-valvular atrial fibrillation stroke and major bleeding events less .
"In addition to clinical trials outside, rich health insurance available data provides us with an excellent opportunity to broaden knowledge about oral anticoagulant use and patient outcomes," principal investigator John Seeger (PharmD, DrPH, of Harvard Medical School teaching affiliated Brigham Department of Medicine Women's Hospital) said. "These real-world data to further define the safety and efficacy of dabigatran patients and their use in conventional therapy, and consistent with the results of RE-LY® pivotal clinical trials."
The primary outcome was all-Thai Bi ® and stroke and the incidence of serious bleeding during warfarin therapy, which involves both the insurance database collected over 32 months, involving 44,672 cases of atrial fibrillation (propensity index matched 22,336 for the first time to accept the Thai Bi Full ® and warfarin-treated patients) data -Truven MarketScan (18,276 patients / group) and Optum Clinformatics (4,060 patients / group). Thai ® treatment group report complete full 65 strokes (incidence of 0.73 / 100 patient-years), and warfarin therapy group report 78 (incidence of 1.08 / 100 patient-years) compared with warfarin, Thai complete whole ® 28% lower risk of stroke (HR 0.72; 95% CI 0.52 - 1.00). In addition, the Thai ® treatment group completed the full report of 395 major bleeding events (incidence rate of 4.47 / 100 patient-years), while the contrast of warfarin treatment group reports 459 major bleeding events (incidence rate of 6.42 / 100 patient-years), That said, compared with warfarin, Thai complete whole ® reduced the risk of major bleeding events by 26% (HR 0.74; 95% CI 0.64 - 0.84). Thai ® treatment group report complete full 238 gastrointestinal bleeding events (incidence of 2.69 / 100 patient-years), while warfarin-treated patients from 213 (incidence of 2.97 / 100 patient-years) (HR 0.95; 95% CI 0.79 - 1.14).
While there are two on the AHA released the latest data on dabigatran idarucizumab of specific reversal agent. One pair of the ongoing Phase III interim analysis data RE-VERSE AD ™ trials showed that the administration may at any time after the restart idarucizumab alternative antithrombotic treatment. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab treatment after the introduction of an alternative antithrombotic therapy (such as heparin) time range is from 0.2 to 77.2 days, whereas for patients requiring emergency surgery or interventional procedures is 0 days to 40.8 days. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab restart time after treatment dabigatran treatment is 1.3 to 90.6 days, and require emergency surgery or interventional procedures in patients time is 1 to 63.31 days.
"Consideration should be given appropriate time to restart as soon as possible antithrombotic therapy to reduce the potential risk of stroke in patients with non-valvular atrial fibrillation," Thomas Jefferson University in Philadelphia, vice provost, professor of emergency medicine and RE-VERSE AD ™ principal investigator Dr. Charles Pollack He said: "The results of this interim analysis of a phase III study RE-VERSE AD ™ broadens the doctors start anticoagulant therapy again at the need to give idarucizumab rare emergency situations, the role reversal of dabigatran after cognition."
Idarucizumab second report included a study of coagulation factor complex [for example, recombinant coagulation factor Ⅶa, 3- or 4-factor prothrombin complex concentrate (PCC) and activated PCC] in vitro efficacy studies idarucizumab presence. The results show, idarucizumab reversal of the anticoagulant effect of dabigatran against clotting factor complex [3]. This result is very important because often the management of acute bleeding in patients using these drugs. The study also showed that the use has been listed idarucizumab not inhibit other anticoagulants (direct factor Xa inhibitor, heparin or other direct thrombin inhibitor) anticoagulant effect.

High levels of carbon monoxide in exhaled volume and risk of stroke and transient cerebral ischemic attack related

A new study shows that high levels of exhaled carbon monoxide levels and stroke and transient ischemic attack (transient ischemic attack, TIA) risks associated, and with a higher burden of subclinical cerebrovascular diseases have some relevance. The results published in the 2015 American Heart Association (AHA) annual meeting.
Dr. Matthew G. Nayor et al Brigham and Women's Hospital analyzed 3313 participants from the Framingham Offspring Study, and no evidence of stroke or TIA at baseline. All participants underwent a measurement of the amount of carbon monoxide exhaled, based on the concentration of carbon monoxide in exhaled stratified by tertiles (≤4 millionth [parts per million, ppm];> 4ppm to <5ppm; ≥5ppm). In addition, 1,982 participants were cranial MRI scans.
Researchers conducted an analysis of the entire cohort, and for 2819 non-smokers were analyzed, with an average follow-up time was 12.9 years.
Nayor et al reported that after adjusting for age and gender, the amount of carbon monoxide in exhaled lower third of the participants in the previous whole brain volume, white matter hyperintensity volume higher and higher proportion of asymptomatic cerebral infarction (P <0.05).
After the exclusion of smokers, the relationship with whole brain volume and white matter hyperintensity volume still exists and adjusted multivariate relationships with white matter hyperintensity volume still exist (P = 0.04).
After adjusting for age and gender, and compared to 1/3 in the 1/3 (HR = 1.67; 95% CI, 1.2-2.32) and former 1/3 (HR = 1.97; 95% CI, 1.41-2.76 ) the risk of stroke and TIA increases. The exclusion of smokers, this result still holds (in 1/3: HR = 1.68; 95% CI, 1.21-2.35; before 1/3: HR = 1.63; 95% CI, 1.09-2.44).
When Nayor, who adjust vascular risk factors, the results weakened to some extent, but after further adjustment BNP and C-reactive protein, this result remains.
"In order to explore the relationship between the biological mechanisms of carbon monoxide and stroke, still need further study." Nayor, who said in the summary.

Walk with it, effectively lowering blood pressure

 Researcher Dr. Maria Chiu said that we need to walk instead of driving this more convenient way, because the walk can help improve the body's health, but this study or may prompt people to exercise in a positive way to effectively reduce the daily life blood pressure, help improve the body's health. (Bolise Co., Ltd  www.acridine-raw-material.com/)





 Moving to a walking neighborhood is good for your blood pressure
People who moved from a neighborhood that required a vehicle to run errands to one that made walking-errands convenient were significantly less likely to have high blood pressure than people who moved from one low-walkability neighborhood to another low-walkability neighborhood, according to research presented at the American Heart Association's Scientific Sessions 2015.
To determine a neighborhood's walking friendliness, researchers used Walk Score, which rates neighborhoods from 1 to 100 for accessibility by foot to stores, parks, schools and other destinations. "Walker's Paradise" neighborhoods received a score of 90 or greater. Walk Score is an open-access walkability index available at http://www.walkscore.com.
This is the first study to determine whether moving to a walking-friendly neighborhood affected blood pressure. Researchers compared 1,057 pairs of adults from the Canadian Community Health Survey (2001 to 2010), who moved from a low walkability neighborhood to either a high walkability or another low walkability neighborhood in Ontario, Canada. Blood-pressure data was obtained from linked health administrative databases held and analyzed at the Institute for Clinical Evaluative Sciences and patients were monitored for up to 10 years.
Researchers found that people who moved to a walking-friendly neighborhood had a 54 percent lower risk of high blood pressure than people who left one walking-unfriendly neighborhood for another.
High blood pressure is one of the main risk factors for heart disease—the leading cause of death in the United States—and for stroke, which is the fifth-leading cause of death. Studies show that an active lifestyle can help reduce the risk of all three of these diseases. For most healthy adults, the American Heart Association recommends at least 150 minutes of moderate exercise, like walking, or 75 minutes of vigorous activity (or a combination of both) each week as part of a heart-healthy lifestyle called My Life CheckTM- Life's Simple 7.

Boehringer Ingelheim announced results of a new analysis of idarucizumab

Boehringer Ingelheim announced two assessments recently approved and listed by the trade name Praxbind® rapid approval process in the United States idarucizumab (Thai Bi Full ® (dabigatran etexilate) is a specific reversal agent) of the new analysis results The results are published in the 2015 American Heart Association (AHA) Scientific Sessions in Orlando held. [1, 2] A study of the administration is started again after idarucizumab antithrombotic therapy analysis. [1] Non-valvular atrial fibrillation anticoagulation treatment is very important to start again, to help rule out the potential risk of stroke.
One pair of the ongoing Phase III interim analysis data RE-VERSE AD ™ trials showed that the administration may at any time after the restart idarucizumab alternative antithrombotic treatment. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab treatment after the introduction of an alternative antithrombotic therapy (such as heparin) time range is from 0.2 to 77.2 days, whereas for patients requiring emergency surgery or interventional procedures is 0 days to 40.8 days. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab restart time after treatment dabigatran treatment is 1.3 to 90.6 days, and require emergency surgery or interventional procedures in patients time is 1 to 63.31 days. [1]
"Consideration should be given appropriate time to restart as soon as possible antithrombotic therapy to reduce the potential risk of stroke in patients with non-valvular atrial fibrillation," Thomas Jefferson University in Philadelphia, vice provost, professor of emergency medicine and RE-VERSE AD ™ principal investigator Dr. Charles Pollack He said: "The results of this interim analysis of a phase III study RE-VERSE AD ™ broadens the doctors start anticoagulant therapy again at the need to give idarucizumab rare emergency situations, the role reversal of dabigatran after cognition."
idarucizumab second report included a study of coagulation factor complex [for example, recombinant coagulation factor Ⅶa, 3- or 4-factor prothrombin complex concentrate (PCC) and activated PCC] in vitro efficacy studies idarucizumab presence. The results show, idarucizumab reversal of the anticoagulant effect of dabigatran against clotting factor complex. [2] This result is very important because often the management of acute bleeding in patients using these drugs. The study also showed that the use has been listed idarucizumab not inhibit other anticoagulants (direct factor Xa inhibitor, heparin or other direct thrombin inhibitor) anticoagulant effect.
"These are analyzed from the interim AD ™ test period III RE-VERSE resulting data show idarucizumab antithrombotic therapy may allow doctors to manage more flexible, and better control over treatment decisions to accept dabigatran-treated patients did . "Professor Jorg Kreuzer cardiovascular therapeutic area vice president of medical Boehringer Ingelheim said," Today published data support the following observations, although in the case of the clinical need to use idarucizumab very little, but doctors and patients, specificity Reversal agents may provide an important treatment option. "

Pharmaceutical Marketing will be the new tactics, double eleven renamed "festival to be"

November 11 this year, in addition to the "double eleven" and "Singles", it will be given a new name - "to be the section."
Lee Jin will put forward the concept of "to be festival" - the only access to the State Food and Drug Administration (CFDA) approved premature ejaculation (PE) indications of therapeutic drugs, US 纳里尼's leading brand in the field of men's health , take a digital "11" (yāo yāo) euphony, in carrying out the whole of society on November 11 each year, especially the "light of love family" creative festival. The name not only fit the event date, it is the original "crazy shopping day" interpretation of the "Live Flesh" means.
First on the line is "do not want to leave early to the section" index big test, by five multiple-choice questions, encouraged to users according to their sex life in actual experience to answer, according to the score for the user, "Ai-ai control of power" to judge, score 0 -20, the higher the score the more the problem described control of power, generally more than 10 points will exist PE problem, along with "control of the Raiders," so that the patient under control.
For a long time, it will facilitate strength has always stressed that "control" the diagnosis and treatment of premature ejaculation critical role, the strength will benefit also launched a new mobile game: "control love heat", with the "boil water" and control of the furnace love analogy, through fun reaction force test, hoping to bring people out of PE cognitive errors, from the blind pursuit of length of time, directed to control up. But also changed a lot of people had misconceptions as to reduce the sensitivity is the key to treatment, in fact, lies in the core of treatment centers in the brain nerve conduction, and the current strength will benefit only the efficacy of oral drugs for the core issues.
What is the "double eleven" hottest topic is? In addition to the women longer than toilet paper 'buy buy buy' list, as well as those of the men behind the endless stream of "anti-chop hand guide." The upcoming 1111 "Caring hand chop Party Guide", in addition to a variety of inventory men "adopted piecemeal" means, but also will release anti-chop hand big trick - that is "directly relent and let your persistence and TA Sweet has been lingering and lasting until after midnight, "baby off the shelf, easy to get rid of double eleven spell.
In addition, PE treatment somewhat similar to chronic disease management requires long-term adherence, it will benefit Jin also introduced a more suitable treatment needs six more affordable equipment specifications and specifications, making the cost of treatment was reduced to 500 yuan per month or even less than 400 Within yuan, which compared to many hundreds of thousands of non-formal treatment programs, not only on the effect of the patient at ease, but the price is also much easier for patients to accept.
Jin will benefit the series of activities, not only by the sweltering October 28 International Men's Health Day, but also to catch under the "double-October" promotion of the electricity supplier tide, two-pronged approach, out of a pharmaceutical marketing New Road. Health science + patient education, so that strict drug brand to take off the heavy coat and becomes "do not have fun." Men's health care, scientific understanding of PE, take the right treatment.

Drug clinical trial data on-site verification points

In order to standardize drug clinical trial data on-site verification, China Food and Drug Administration formulated the "drug clinical trial data on-site verification points", hereby release and related matters are announced as follows:
 First, China Food and Drug Administration will apply for registration under "drug clinical trial data on-site verification points", for complete self-examination information furnished one by one drug clinical trial data on-site verification.
 Second, some of the drugs clinical trial data from the on-site verification of the case has been completed, the part of the drug clinical trial institution exists unauthorized modification of data, data, and data is not traceable concealed fraud and other issues, China Food and Drug Administration announced the discovery along together, and The applicant for registration, clinical trials institutions, clinical trials contract research organizations and related persons responsible be severely dealt with according to law.
 Third, clinical trials or clinical trials contract research organization should continue in accordance with the "drug clinical trial data on-site verification points", the authenticity of test data integrity self-examination, found unreal problems, countries should take the initiative to report Food and Drug Administration, and the initiative to urge the applicant to withdraw the application. Clinical trials contract research organization or organizations proactively report problems, may be exempted from accountability.
 Fourth, the applicant has found that the presence of drug registration clinical trial data authenticity may be directed to China Food and Drug Administration for withdrawal. In the China Food and Drug Administration notice on-site verification of application is withdrawn before the initiative, publish a list of applicants and varieties, not to be held accountable; after notification to accept the withdrawal of the application is no longer on-site verification.

Antipsychotic new drug brexpiprazole in improving symptoms significantly better than placebo

A study published in September, "American Journal of Psychiatry," the multi-center randomized double-blind controlled study, Hofstra University, USA - North Shore Medical Christoph U. Correll et al found that, for patients with acute exacerbation of schizophrenia, 2mg / d and 4mg / d of new drugs brexpiprazole antipsychotic in terms of improvement of symptoms was significantly better than placebo and well tolerated.
Dr. Donald C. Goff, New York University Medical Center for the drug with the Journal commented, the following main points of Dr. Goff:
In this study, 2mg and 4mg of brexpiprazole valid and 0.5mg invalid. This study shows us the short-term efficacy of the drug compared to placebo, but the lack of an active control of the design makes it difficult to predict the market compared to other antipsychotics, brexpiprazole exactly what advantages or disadvantages. And, brexpiprazole turned out coincides with many of the existing second-generation antipsychotics patents expire, including aripiprazole (aripiprazole), and imitation will wind current and future health care budget tremendous impact.
Similar to aripiprazole, brexpiprazole also D2 receptor partial agonist. By the relatively weak endogenous dopamine D2 receptor activation effect, D2 partial agonist reduces the maximum delivery of the "ceiling", while lower activity levels increased D2 receptor. Above mechanism aimed at achieving a balance: D2 receptor by agonistic effect sufficient to prevent neural side effects (extrapyramidal reactions) and hyperprolactinemia, but also to avoid excessive D2 receptor activity; D2 receptor activity It can reduce the effects of high anti-psychotic drugs, and lead to certain related side effects.
As previously sink like a stone a D2 receptor partial agonist, bifeprunox, its intrinsic activity for the D2 receptor stronger than aripiprazole. The result is that antipsychotic efficacy of the drug in inferior currently being used, while D2 receptor agonist effect and cause nausea and vomiting. In fact, we can speculate, as D2 receptor agonists, anti-psychotic effects of aripiprazole may also be weaker than other antipsychotics; however, head to head comparison of the current evidence is still limited, as far as the efficacy of aripiprazole still in the middle ranks of the second-generation antipsychotics. Essentially, aripiprazole without causing hyperprolactinemia and extrapyramidal symptoms, but as a D2 receptor agonist symptoms, nausea, insomnia and would rather not appear in the early treatment of some patients.
D2 receptor internalization activity of dopamine itself is 100%, brexpiprazole 43%, aripiprazole was 61%, bifeprunox 84%. From this perspective, among aripiprazole and D2 receptor antagonist antipsychotics brexpiprazole ranked. The absence of other factors being equal, people can predict, brexpiprazole efficacy and extrapyramidal reactions / prolactin increased risk of the same center. However, unlike aripiprazole it is different, the higher brexpiprazole with 5-HT1a receptor affinity, the same as a partial agonist; and 5-HT2a and α1b and 2c receptor also has an affinity for the potential antagonistic effects. Compared to aripiprazole, brexpiprazole above properties more similar to other second-generation antipsychotics, which may be helpful for efficacy.
In this study, despite a relatively prominent placebo effect exists, but the efficacy of 2mg and 4mg brexpiprazole still conclusive, involving positive improvement in negative symptoms and overall outcome indicators. However, Similarly, the use of placebo-controlled design BEACON study, after six weeks of treatment brexpiprazole just 4mg / d was significantly better than placebo. Two studies of adverse reactions similar situations, such as 4mg group and moderately associated with weight gain, an increase of about six weeks 1kg, prolactin also increased slightly. Correll's study, 4mg / d group had akathisia ratio of 7.2%, while the figure in the placebo group was 2.2%; BEACON study, brexpiprazole no significant difference with placebo. brexpiprazole other forms of nerve incidence of adverse reactions similar to placebo, the researchers also affect the drug on cardiac function was not detected. brexpiprazole and changes in blood pressure has nothing to do, but for a period of eight days of dose titration may mask the true situation. Given the extent of extrapyramidal reactions and weight gain / prolactin elevation affected the study sample, the drug previously used the same effect will continue, we will medicine with existing drugs is difficult to compare directly.
In summary, as we learned from the CATIE study until more comparative data, especially randomized study comparing head to head emergence, it is difficult to determine in the market compared to the existing drugs, an anti-psychotic Advantages and disadvantages of how new drugs. A very appealing concept is that clinicians may be based on the sensitivity and efficacy requirements for adverse reactions in patients, from a range of different intrinsic activity of D2 receptor partial agonist be selected. After aripiprazole and D2 receptor antagonist treatment failure, patients will find brexpiprazole "just right"? There may be, but in the open aripiprazole and D2 receptor antagonist antipsychotics between the space occupied by brexpiprazole not necessarily wide to have clinical significance. Head to head comparison or clinical practice, brexpiprazole could come to the fore, we'll see.